A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor

• Status: Completed
• Trial end date: 2020-11-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study will also evaluate the safety of ASP0113 in this patient population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.
• Collaborator: Vical

Criteria

Inclusion Criteria:

• CMV negative subject having received a CMV seropositive kidney (living or deceased)

• Subject started valganciclovir or ganciclovir within 10 days of transplant and has received it through Randomization.

Exclusion Criteria:

• Subject is planned to undergo a course of CMV-specific prophylactic therapy with antiviral drugs with a duration of greater than 100 days.

• Subject has received from one month prior to transplant or is planning to receive CMV immunoglobulin.

• Subject has had CMV viremia or CMV disease from time of transplant until time of Randomization.